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EL Krawitt, LM Blatt, MJ Tong, WM Lee, K Mullen, JC Hoefs, E Keeffe, FB Hollinger, EJL Heathcote, H White, RT Foust, DM Jensen, H Fromm, M Black, D Albert, T Gerrard and the Consensus Interferon Study Group University of Vermont, Burlington, VT, Amgen Inc., Boulder, CO and the CIFN study sites

Chronic HCV patients with low baseline viral concentrations have been shown to be highly sensitive to treatment with interferon alpha 2. In order to assess the response to CIFN, a novel non-naturally occurring type 1 interferon, to chronic HCV patients with low baseline viral concentrations, we analyzed data from the phase 3 CIFN clinical trial. In this study, 232 patients with chronic HCV infection were treated with CIFN at a dose of 9 µg three times weekly (TIW) for 24 weeks followed by 24 weeks of observation. HCV RNA concentrations were determined using a quantitative RT-PCR assay that had a lower limit of detection of 100 copies/mL. Low HCV RNA titer was defined as a baseline HCV RNA concentration of <=1.15 x10{6} copies/mL which represented the lower 25% quartile for the baseline HCV RNA concentration distribution of all the patients enrolled in this study. Responses for HCV RNA <=1.15x10{6} copies/mL (low titer) and HCV RNA >=1.15 x 10{6} copies/mL were assessed by measurement of changes in serum ALT and HCV RNA values (quantitative RT-PCR analysis)(Table 1). Table 1. Response Rates in Low Titer Chronic HCV Patients.

     Percent HCV RNA               Percent
                           Negative                  ALT Normal
     Group             End of     End of          End of     End of
                   N  Treatment  Observation     Treatment  Observation
     HCV RNA      55     51%        24%*            60%        35%*
     <=1.15 x10{6}
     HCV RNA     177     30%         8%*            37%        16%*
     >=1.15 x 10{6}
     p<0.01 for both comparisons
A statistically significant difference in the number of sustained HCV RNA and ALT responders was observed at the end of observation for patients with low baseline HCV RNA titers as compared to the responses seen in the patients with baseline HCV RNA above the 1.15 x 10{6} copies/mL cutoff (p<0.01 for both comparisons). These data confirm previous observations that chronic HCV patients with low baseline viral titers respond to IFN treatment better than patients with higher baseline viral loads. This research was funded by Amgen Inc., boulder, CO.

Source: American Association for the Study of Liver Diseases - 1996 Annual Meeting

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